Deflectable sheath introducer

ABSTRACT

An introducer has a shaft with a central lumen, a control handle with a deflection assembly, and a tensile member with a distal portion extending along opposing sides of within the shaft and a proximal portion extending within the control handle. The deflection assembly has a deflection arm, and a rotatable member rotationally coupled to the deflection arm, wherein the rocker member has at least one pulley engaged with the proximal tensile member portion. Rotation of the deflection arm in one direction draws the proximal tensile member portion for deflecting the shaft.

FIELD OF INVENTION

The present invention relates to sheath introducers for use withcatheters, and in particular, deflectable sheath introducers withcontrol handles.

BACKGROUND OF INVENTION

Electrode catheters have been in common use in medical practice for manyyears. They are used to stimulate and map electrical activity in theheart and to ablate sites of aberrant electrical activity. In use, theelectrode catheter is inserted into a major vein or artery, e.g.,femoral artery, and then guided into the chamber of the heart which isof concern. Within the heart, the ability to control the exact positionand orientation of the catheter tip is critical and largely determineshow useful the catheter is.

The Seldinger technique is a medical procedure for insertion of heartcatheters including central venous catheters. It is named after Dr.Sven-Ivar Seldinger (1921-1998), a Swedish radiologist. The techniqueinvolves puncturing the vein and inserting a guiding sheath, a guidewireand a dilator into the patient, as is generally known in the art. Thedilator is removed, and a catheter is introduced through the guidingsheath whereby a guidewire lumen in the catheter allows the catheter topass over the guidewire. The guidewire is then removed. For devices nothaving a guidewire lumen, the guidewire is removed prior to insertion ofthe device to allow passage. Once the distal end of the catheter reachesthe desired location, the guiding sheath is withdrawn to expose thedistal end of the catheter which may comprise an electrode assembly formapping and/or ablation and any other structures to stabilize theelectrode assembly in the heart or against the heart wall and tissue.Fluoroscopy may be used to confirm the position of the catheter and tomaneuver it to the desired location. Injection of radiocontrast may beused to visualize organs. The sheath may be used for both right-sidedprocedures, and transseptal electrophysiologic procedures that requirepuncturing of the septum.

Bidirectional catheters have been designed to be deflectable in onedirection by one puller wire and in the opposite direction within thesame plane by a second puller wire. In such a construction, the pullerwires extend into opposing off-axis lumens within the tip section of thecatheter. So that the tip section can bend in both directions in thesame plane, the puller wires and their associated lumens are locatedalong a diameter of the tip section. Such catheters typically have acontrol handle at their distal end which have a thumb knob and/or arotatable grip that is manipulated by an electrophysiologist to positioncatheter distal end at the desired location and/or operate electrodeassemblies, such as contraction, expansion, deployment, retraction, etc.

Deflectable sheaths are also known, however, the deflection mechanismrotates around the axis of the control handle which facilitatestwo-handed manipulation but is not ideal for single-handed deflection.Thus, the operator cannot simultaneously deflect the sheath and thecatheter extending through the sheath. Existing sheaths also use a softdistal tip with an embedded marker band which does not allow for optimalvisualization of the most distal tip and does not provide extensive tipflexibility. Moreover, existing sheaths utilize a consistentcross-sectional profile along the longitudinal axis of the deflectablesection which does not allow for changing of stiffness properties nearthe distal end.

Accordingly, it is desirable to provide a sheath introducer that hasbidirectional deflection and a control handle that allows an operator tomanipulate with one hand so he can simultaneously operate the controlhandle of the catheter extending through the sheath introducer. It isalso desirable to provide a shaft, and more specifically a deflectablesection of the sheath introducer, with sections of different durometerso that flexibility and softness varies near the distal end of theshaft, and in particular, with increased flexibility and softness towardthe distal tip of the shaft. It is further desirable that the distal tipbe radiopaque for optimal visualization and that the distal tip forms aseal with the catheter or device extending through the shaft so thatminimal force is used during punctures and risk of distal tip prolapsingis reduced.

SUMMARY OF THE INVENTION

The present invention is directed to a deflectable sheath introducerhaving a shaft through which a catheter, needle or device can extend,and a control handle incorporating a deflection assembly that anoperator can manipulate for deflecting a deflectable region near adistal section of the shaft, wherein the deflection assembly has adeflection member, a rotatable rocker member and at least a pulley thatis engaged with a portion of a tensile member. Rotation of thedeflection member about an axis generally perpendicular to alongitudinal axis of the control handle draws on the tensile member todeflect the shaft.

In one embodiment, the introducer has a shaft with a central lumen, acontrol handle with a deflection assembly, and tensile members each witha distal portion extending along opposing sides of within the shaft anda proximal portion extending within the control handle. The deflectionassembly has a deflection arm, and a rocker member rotationally coupledto the deflection arm, wherein the rocker member has at least twopulleys, each engaged with a respective proximal tensile member portion.Rotation of the deflection arm in one direction draws one proximaltensile member portion for deflecting the shaft in the one direction,and rotation of the deflection member in an opposite direction draws theother proximal tensile member portion for deflecting the shaft in theopposite direction.

In more detailed embodiments, the tensile member has a distal pullerwire portion and a proximal fiber portion, and the deflection assemblyincludes a tension knob for adjusting tension of the deflection member.The shaft extends through the rocker member which has cutout so that therocker member can rotate without interference from the shaft. The shaftmay include a softer and more flexible distal section, with a distal tipof a conical cross-section that forms a fluid-tight seal with the devicebeing guided by the introducer. The shaft is formed with opposingoff-axis channels for passing the tensile member along the length of theshaft distal of the control handle. With in the control handle, thetensile member is generally outside of the shaft so it can engage with apulley of the deflection assembly. At the distal section of the shaft,the tensile member may pass radially across a ring attachment foranchoring the tensile member in the distal section.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will bebetter understood by reference to the following detailed descriptionwhen considered in conjunction with the accompanying drawings wherein:

FIG. 1 is a top view of an embodiment of the sheath introducer of thepresent invention for use with a device inserted therethrough.

FIG. 2 is top view of an interior of an embodiment of a control handlewith a deflection assembly.

FIG. 3 is a perspective view of an embodiment of a control handle with atension knob and a deflection member.

FIG. 4 is a perspective top view of an embodiment of a rotatable rockermember.

FIG. 5 is a perspective bottom view of an embodiment of a rocker member.

FIG. 6 is a perspective view of an embodiment of an interior of acontrol handle with a rocker member and tensile members.

FIG. 7 is a side elevational view of an embodiment of a pulley.

FIGS. 8 a-c show an embodiment of a control handle with its deflectionassembly in a neutral position, deflection to the right and deflectionto the left.

FIG. 9 a is a side cross sectional view of an embodiment of a distalsection of a shaft of the introducer 10.

FIG. 9 b is a longitudinal cross sectional view the distal section ofFIG. 9 a, taken along line b-b.

FIG. 9 c is a longitudinal cross sectional view of the distal section ofFIG. 9 a, taking along line c-c.

FIG. 9 d is a longitudinal cross sectional view of the shaft of FIG. 8,taken along line d-d.

FIG. 9 e is a longitudinal cross sectional view of the shaft of FIG. 2,taken along line e-e.

FIG. 9 f is a side cross sectional view of an alternate embodiment of adistal section of a shaft of the present invention.

FIG. 10 a is a side cross sectional view of an alternate embodiment of adistal tip section of a shaft.

FIG. 10 b is a side cross sectional view of another alternate embodimentof a distal tip section of a shaft.

FIG. 11 is a longitudinal cross sectional view of an embodiment of adeflection assembly of the control handle.

FIG. 11 a is a detailed view of a portion of the deflection assembly ofFIG. 11, showing a bolt and a retaining nut.

FIG. 12 is a perspective view of an embodiment of a tension knob.

FIG. 13 is a perspective view of an embodiment of a locking plate.

FIG. 14 is a perspective of an embodiment of an assembly including thetension knob and the locking plate.

FIG. 15 is a perspective view of an embodiment of a control handle.

FIG. 16 is a partial perspective view of an embodiment of an interior ofone housing half of a control handle.

FIG. 17 is a partial perspective view of an embodiment of an interior ofanother housing half of a control handle.

FIG. 18 is a perspective view of an embodiment of a deflection member.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1 and 2 illustrate an embodiment a steerable bidirectional sheathintroducer 10 for use with a catheter, needle or other device 20 (usedinterchangeably herein) to be extended through the introducer 10 forentry into a patient's body. The introducer 10 comprises an elongatedshaft 12, and a control handle 16 at the proximal end of the shaft 12.Distally, the shaft 12 has a deflectable section 15 and a distal tipsection 14. The shaft 12 has a central lumen 18 that extends its entirelength for passage of the catheter or other device 20. The shaft 12extends both distally of the control handle 16 and proximally throughthe control handle.

For deflecting the deflectable section 15 of the shaft 12, tensilemembers 22 are provided, with their distal ends anchored at or near thedistal tip section 14 and their proximal ends anchored in the controlhandle 16. Longitudinal movement of the tensile members relative to theshaft 12, which results in deflection of the deflectable section 15, isaccomplished by means of the control handle 16 and its deflectionassembly 24.

With reference to FIGS. 1-3, the control handle 16 comprises a generallyelongated handle housing, which can be made of any suitable rigidmaterial, such as plastic configured through a suitable molding process.In the illustrated embodiment, the housing includes two opposing halves26 a and 26 b that generally mirror each other and are joined by glue,sonic welding or other suitable means along a longitudinal peripheralseam 28 around the housing. The shaft 12 enters the control handle 16 atits distal end (FIG. 2), extends along the longitudinal axis of thecontrol handle 16 and terminates at the proximal end of the controlhandle in a hemostatis valve 30 (FIG. 1) that has been integrated intothe housing of the control handle. The hemostatis valve forms a fluidtight seal with the device 20 for various purposes, including keepingthe lumen 18 of the shaft 12 at positive pressure to prevent patient'sloss of blood through the introducer 10 and minimizing the introductionof air into the patient's body. Moreover, the hemostatis valve 30connects to a side port 13 having a luer hub 17 through which a vacuumcan be created to remove air from the inner lumen 18 or through whichfluids can be flushed into the lumen 18 to prevent blood from clotting.

The control handle 16 houses components of the deflection assembly 24(FIG. 3) which includes a deflection member or arm 36 that can bedirectly manipulated by an operator to control deflection of the shaft12. The deflection arm 36 is rotatable about an axis 19 that isgenerally transverse or perpendicular to the longitudinal axis of thecontrol handle. As illustrated in FIGS. 4-6, the deflection assembly 24has a rotatable rocker member 38 that acts on the tensile puller members22 to deflect the shaft 12. The rocker member 38 has a length Ldimension, a width W dimension and a thickness T dimension.

Along its thickness dimension, the rocker member 38 is configured withtwo opposing annular formations 40 a and 40 b that define a central hole43 that extends through the thickness of the member 38. The central hole43 defines an axis of rotation 44 that is coaxial with rotational axis19 of the deflection arm 36. Along its length, the rocker member 38 alsohas two smaller holes 46 that oppose each other from the central hole43. In each hole sits a pulley 47, for example, a snap bearing (FIG. 7),that has a rotational axis parallel to the rotational axis 19. A tensilemember 22 enters the rocker member through slots 48 and a portion iswound around a respective pulley 47.

To accommodate the shaft 12 extending across and through the controlhandle 16, the rocker member 38 has a channel 50 extending through itswidth. Distal and proximal portions of the channel 50 have indents,e.g., triangular or wedge-shaped, 51 (FIG. 2) to allow the rocker member38 to rotate freely within a predetermined range of angles, e.g., about±45 degrees of the longitudinal axis of the control handle 16, withoutinterference with the shaft 12.

As understood by one of ordinary skill in the art, the rocker member 38and the pulleys 47 are arranged such that rotation of the rocker memberin one direction about the axis 44 draws back one tensile member 22 todeflect the shaft 12 in that direction. With reference to FIGS. 8 a-8 c,as the rocker member 38 is rotated by means of the deflection arm (asrepresented by line 36), the pulleys 47 are displaced from a neutralposition (FIG. 8 a) with one pulley 47 drawing a tensile member 22 onone side of the shaft 12 against its anchored proximal end 53 fordeflecting the shaft toward that side (FIGS. 8 b and 8 c).

Each tensile member 22 may comprise multiple segments. As bestillustrated in FIG. 2, each tensile member has a distal puller wireportion 22 a and a proximal tensile fiber portion 22 b that are joinedor connected at a location with in the control handle 16 distal therocker member 38. The puller wire portions 22 a and the tensile fiberportions 22 b are connected or secured to each other by a connector 54,e.g., a crimped brass ferrule covered by shrink tubing. The puller wireportions 22 a extend nearly the entirety of shaft portion 12 a distalthe control handle. The tensile fiber portions 22 b extend inside thecontrol handle 16 generally outside proximal shaft portion 12 b. In thismanner, it is the more flexible tensile fiber portions 22 b thatinteract with the pulleys 47 and undergo repeated bending andstraightening during deflection operations, as they are less prone tobending stress and fatigue failure.

Each puller wire portion or puller wire 22 a is made of any suitablemetal, such as stainless steel or Nitinol. Preferably each puller wirehas a low friction coating, such as a coating of Teflon® or the like.Each puller wire has a diameter preferably ranging from about 0.006 inchto about 0.012 inch. Preferably both of the puller wires have the samediameter. Flat puller wires may be used in place of round puller wires.Their cross sectional dimensions should be such that they providecomparable tensile strengths as round puller wires.

Each tensile fiber portion or tensile fiber 22 b may be of a highmodulus fiber material, preferably having an ultimate tensile strengthsubstantially in the range of 412-463 ksi (2480-3200 Mpa) such as HighMolecular Density Polyethylene (e.g., Spectra™ or Dyneema™), a spunpara-aramid fiber polymer (e.g., Kevlar™) or a melt spun liquid crystalpolymer fiber rope (e.g., Vectran™), or a high strength ceramic fiber(e.g., Nextel™). The term fiber is used herein interchangeably with theterm fibers in that the tensile fiber may be of a woven or braidedconstruction. In any case, these materials tend to be flexible,providing suitable durability when used in wrapped engagement with thepulleys and the like for greater throw in deflecting the catheter tip.Further, they are substantially non-stretching, which increases theresponsiveness to the manipulation of the control handle, andnonmagnetic so that they generally appear transparent to an MRI. The lowdensity of the material causes it to be generally transparent to anx-ray machine. The materials can also be nonconductive to avoidshorting. Vectran™, for example, has high strength, high abrasionresistance, is an electrical insulator, nonmagnetic, is polymeric, andhas low elongation under sustained loading conditions.

In the illustrated embodiment of FIGS. 9 a-9 e, the shaft 12 comprisesan elongated tubular construction having a single, axial or centrallumen 18, and two considerably smaller off-axis channels or lumens 42,one on each side of the central lumen 18 along a diameter of the shaft12. Each channel 42 may be lined by a compression coil or stiffener 41(FIG. 9 b) from the proximal end of the shaft 12 at the hemostatis valve30 inside the control handle 16 to a proximal end of the deflectablesection 15 (FIG. 1) to resist buckling during deflection of thedeflectable section 15. Lining the lumen 18 of the shaft 12 is an innerlayer or lining 60 (e.g., of PTFE or TEFLON®) which reduces friction andenhances smooth passage of a catheter or device through the shaft. Thelining 60 is surrounded by a braided mesh 62 of stainless steel or thelike that is covered by an outer layer body 64. The braided mesh 62increases the torsional stiffness of the shaft 12 so that when thecontrol handle 16 is rotated the distal end of the shaft 12 will rotatein a corresponding manner. The outer layer 64 may be made of a suitablepolymer, such as polyurethane or PEBAX® (polyether block amide). Ifextruded, the outer layer 64 can better bond the braided mesh 62 to thelining 60. For an 8 french sheath introducer, the outer diameter of theshaft 12 is preferably no more than about 12.5 french, more preferablyabout 11.5 french. The inner diameter or central lumen 18 of the shaftis preferably no less than about 8 french, more preferably between about8.25 and 8.5 french. The off-axis channels 42 may be formed in the outerlayer 64 during extrusion or molding for shafts manufactured with suchprocesses. The channels 42 may also be formed by means of a round orflat tube (of PTFE or other suitable material) during lamination of theouter layer. It is understood by one of ordinary skill in the art thatthe material, shape and size of the tube may vary to accommodate varioustensile member designs and materials.

With reference to FIGS. 6 and 9 d, a port or opening 66 is cut orotherwise provided at a location along the proximal shaft portion 12 aextending within the control handle 16 to allow the tensile members 22to enter the off-axis channels 42. In the illustrated embodiment, thedistal puller wire portions 22 a of the tensile member passes into theopenings 66 and extend distally into the channels 42 of the shaft.

Distally, the shaft 12 includes a distal tip section 14 distal of thedeflectable section 15. The distal tip section comprises a conical tip70, a fastener, e.g., a ring attachment 72, for the tensile member and atransition portion 74 that bridges the deflectable section 15 and theconical tip 70. The conical tip can be made of a soft, radiopaquematerial. The central lumen 18 extends through the distal tip section14. Although the outer layer 64 of the shaft terminates at the proximalend of the distal section 14, the lining 60 and the braided mesh 62 ofthe shaft 12 extend into the transition portion 74 and are covered by anouter layer 76. In the disclosed embodiment, the outer layer 76 has adifferent durometer than the outer layer 64 so that the transitionportion 74 can be softer and more flexible than the shaft 12. Forexample, the outer layer 76 can be a softer and more flexible cannulamaterial. As illustrated, the off-axis channels 42 continue extendthrough the outer layer 76. Furthermore, the outer layer 76 of thetransition portion 74 may be comprised of multiple sections 76 a-76 d ofmaterials with different durometers to provide a change in flexibilityof the deflectable region 15 relative to location from the conical tip70 (FIG. 9 f)

The lining 60 extends from the transition segment 74, through theattachment ring 72 and terminates in the conical tip 70. The portion ofthe lumen 18 in the conical tip 70 tapers accordingly with the conicalprofile of the tip 70, with a diameter D of the lumen 18 at a distal endbeing sufficient to allow passage of the device 20 while forming acircumferential fluid-tight seal against the device. To that end, thematerial of the conical tip 70 is elastic to facilitate the formation ofthe seal. Ports 82 are provided in the transition segment 74 through thelining 60, the braided mesh 62 and the outer layer 76 so that fluid canescape from the central lumen 18 to prevent the formation of a vacuum asthe device 20 moves therethrough.

Between the conical tip 70 and the distal end of the transition portion74, the attachment ring 72 serves as an anchor for the tensile membersextending through the off-axis channels 42. With reference to FIG. 9 c,the tensile members 22 a emerging from each off axis channel 42 extendthrough a passage 78 formed in the attachment ring 72 that includesradial passages 78 a that are aligned with the off-axis channels 42 anda circumferential passage 78 b linking the radial passages. In thiscase, it is understood that the tensile members 22 a is a continuousstructure that extends from one channel 42 into the other channel 42.Bonding between the tensile members 22 a and the ring 72 prevents thetensile members 22 a from moving or dislocating. The ring 72 can be madeof a material similar to that of the conical tip 70 and/or thetransition segment outer layer 76, with similar melt temperatures. Thering 72 may be formed by lamination or molding. Interfacing edges orjunctions within the distal section 14, between the conical tip 70, thering 72 and the transitional portion 74 can be joined by thermalbonding, and/or glue or adhesives.

The attachment ring 72 anchors the tensile member 22 so that as aproximal end of the tensile member is drawn proximally by a pulley 47 ofthe rocker member 38 of the deflection assembly 24, the shaft 12 isdeflected toward that tensile member (FIGS. 8 b and 8 c).

Alternatively, the tensile member 22 can pass through holes 84 formed inthe transition segment ring 72 and be wrapped around the outer surfacefor several windings 85 and be affixed to the outer surface bylamination 86 (FIG. 10 a). As another alternate embodiment, the distalends of the tensile member can be anchored to the side wall of the shaft12 by means of a T-bar anchor 88 (FIG. 10 b) as known in the art. Ofcourse, in this case, the tensile members need not be connected orjoined in the distal section of the shaft 12. Other means for anchoringthe tensile members 22 (as either a continuous member or separatemembers) at or near the tip section 14 would be recognized by thoseskilled in the art and are included within the scope of the invention.It is understood that the bi-directional deflection of the deflectablesection 15 can be symmetrical or asymmetrical, planar or nonplanar,depending on various factors, including the location of the distalanchor(s) of the tensile member(s) are anchored and the configuration ofthe off-axis channels 42.

Referring back to FIG. 2, the portions of the tensile members within thecontrol handle 16 are the tensile fiber portions 22 b, each of whichextends proximally from the connector 54 toward the rocker member 38where each is wound around a pulley 47 and turns about 180 degrees todouble back toward the distal end of the control handle. Each proximalend of the tensile member 22 b is anchored by an anchor assembly 90 thatincludes a pair or racks 92, a slug 94 and a stop 96. The proximal endof the tensile member 22 b extends between a respective channel 91defined by the pair of racks 92, and the proximal end of each tensilefiber is encased within a molded member or slug 92 sized to fit in andto translate in the channel 91. Proximal the slug are the stops 96 thatare adjustably positioned in a selected location along the racks 92, forexample, by means of interlocking teeth 98 formed in the racks and thestops to releasably lock in the selected position against movement. Thestops 96 are formed so that each respective tensile fiber 22 b can slidethrough them, below or around them but the stops 96 block the slugs 94from moving proximally past them. Accordingly, the stops 96 limit theproximal movement of the slugs 94 and anchor the proximal ends of thetensile fibers 22 b to effectuate deflection when each is drawnproximally by the deflection assembly 24. During assembly of the controlhandle 16 before the two housing halves 26 a and 26 b are joined, thestops 96 are selectively positioned between the racks 92 to achieve adesirable tension in each tensile member. The interlocking teeth of theracks 92 and stops 96 allow for fine adjustments in setting the tension.

With reference to FIGS. 3 and 11, the deflection assembly 24 alsoincludes a rotation tension knob 100 that allows an operator to set theease with which the deflection arm 36 can be rotated. The constructionand assembly of the deflection assembly 24, inclusive of the deflectionarm 36 and the tension knob 100, are described as follows.

With reference to FIGS. 3, 11, and 11 a, the deflection arm 36 and thetension knob 100 are mounted opposite of each other with the housinghalves 26 a and 26 b of the control handle 16 therebetween. The tensionknob 100 has a generally circular cross section with a circumferentialedge 102 having a friction-inducing surface (FIG. 12). A centralcircular protrusion 105 and two prongs 106 along a diameter project froma surface 104 of the knob 100. A locking plate 103 (FIG. 13) issandwiched between the knob 100 and the housing half 26 b. The lockingplates has a central opening 107 and two holes 108. The two prongs 106of the knob 100 are inserted through the two holes 108 in the plate 103and extend therethrough to engage semi-circular grooves 101 (FIG. 15)formed in an outer surface of the housing half 26 b. The grooves 101limit the degree of rotation of the knob 100 in clockwise andcounterclockwise directions. The central opening 107 of the plate 103(FIG. 13) has different cross-sections that include a larger circularcross-section 109 and a smaller circular cross-section 112. The largercircular cross-section 109 receives a head 114 of a cap screw-type bolt115, and the smaller circular cross-section 112 receives a body 116 ofthe bolt 115. The central protrusion 105 of the tension knob 100 forms apress fit with the head 114 of the bolt 115 to create rotationalalignment between these two components. The prongs 106 lock androtationally couple the tension knob 100 and the lock plate 103, and thebolt 115 is rotationally coupled to the plate 103. Coupling of thetension knob 100 and the locking plate 103 may also be achieved by meansof welding the two components together. In that case, the prongs 106need not protrude from the tension knob but rather from the lockingplate 103.

With reference to FIG. 11, the rocker member 38 is situated between thetwo halves 26 a and 26 b of the control handle 16, with each of annularformations 40 a and 40 b extending respectively through an opening 120 aand 120 b formed in each housing half. The opening 120 b in the housinghalf 26 b (FIG. 16) has a larger circular cross section 122 to receivethe annular formation 40 b, and a polygonal cross-section 124 to receivea matching polygonal cross-section distal end 126 of a retaining nut 136whose head 138 abuts a circumferential edge 132 (FIG. 11) formed in thecentral hole 43 of the rocker member 38. The body 116 of the bolt 115extending through the plate 103 is received in the retaining nut 136 tojoin the tension knob 110 to the rocker member 38, with the housing half26 b and a washer 119 (e.g., Belleville type) secured therebetween. Thepolygonal distal end 126 of the retaining nut 136 rotationally couplesthe nut 136 and the housing half 26 b while a circular body portion 131(FIG. 16) of the nut 136 allows rotational independence between the nut136 and the rocker member 38. Thus, rotation of the knob 100 in onedirection which turns the bolt 115 to advance into the retaining nut 136compresses components including the annular formation 40 b and thewasher 11 against the housing half 26 b which tightens the knob 100.Likewise, rotation of the knob 100 in the opposite direction which turnsthe bolt 115 to withdraw from the nut 136 releases the compression whichloosens the knob 100.

In assembling the deflection arm 36 to the control handle 16, the rockermember 38 is positioned so the annular formation 40 a extends throughthe opening 120 a (FIG. 17) in the housing half 26 a. The annularformation 40 a has recesses 150 (FIG. 4) that lock with protrusions 152projecting from a facing surface 154 of the deflection arm 36 (FIG. 18),which rotationally couple the deflection arm 36 and the rocker member38. The protrusions 152 can snap fit into the recesses 150 and/or besecured by adhesives, glue, sonic welding and the like. A centralcircular protrusion 156 fits into the annular formation 40 a of therocker member 38.

In use, the shaft 12 of the introducer 10 is introduced into a patient'sbody through an opening in a vein. Through the lumen 12 of theintroducer 10, a guidewire is fed, followed by a dilator, as isgenerally known in the art. The dilator is removed, and the device isintroduced through the hemostatis valve 30 at the proximal end of thecontrol handle 16 to enter the central lumen 18 of the introducer 10whereby the guidewire is passed through a guidewire lumen in the device.For devices not containing a guidewire lumen, the guidewire is removedfrom the sheath prior to insertion of the device. The luer hub 17 on theside port 13 can be used to draw or inject fluid into the central lumen18 of the sheath introducer 10 as needed. An electrophysiologist usesone hand to manipulate the control handle 16 of the introducer 10 andhis other hand to manipulate the control handle of the device 20. Theelectrophysiologist can deflect the deflectable region 15 of the shaft12 with one hand while deflecting an exposed deflectable region of thedevice 20 with the other hand. The distal section 14 of the deflectablesection 15 with its increased flexibility can be used to provideimproved positioning capabilities of the device 20. Additionally, thecombined stiffness of the device 20 and the shaft 12 provides improvedback support for the device 20 and aids in maintaining positioning oncethe device 20 is in place. The conical tip 70 of the shaft 12 maintainsa tight seal with the device 20 so that force is minimized duringpunctures. Fluid can enter or leave the central lumen 18 of the distalsection 14 via ports 82 so that there is no vacuum to prevent the device20 from moving freely through the central lumen 18 of the shaft 12.

By rotating the deflection arm 36 to one direction, the deflectablesection 15 (along with the device 20 therethrough) is deflected in thatdirection. By rotating the deflection arm 36 to the other direction, thedeflectable section 15 (along with the device 20 therethrough) isdeflected in the other direction. If the deflection arm 36 rotates toofreely or not readily enough, the electrophysiologist can adjust thetension on the deflection arm 36 by rotating the tension knob 100.

Accordingly, the foregoing description should not be read as pertainingonly to the precise structures described and illustrated in theaccompanying drawings, but rather should be read consistent with and assupport to the following claims which are to have their fullest and fairscope.

1. A deflectable introducer for use with a device for passage into apatient's body, the introducer comprising: a shaft with a deflectablesection, the shaft having a lumen through which the device can extend;an elongated control handle defining a longitudinal axis; a tensilemember extending between the deflectable section and the control handle,wherein the control handle has a deflection assembly comprising adeflection member and a rotatable member, the deflection member beingrotatable about an axis generally perpendicular to the longitudinal axisof the control handle, the rotatable member being rotationally coupledto the deflection member, the rotatable member having a pulley engagedwith a proximal portion of the tensile member situated within thecontrol handle; wherein manipulation of the deflection member in onedirection draws on the tensile member for deflecting the deflectablesection of the shaft in the one direction.
 2. A deflectable introducerof claim 1, wherein the distal portion of the tensile member is a pullerwire and the proximal portion of the tensile member is a tensile fiber.3. A deflectable introducer of claim 1, wherein the deflection assemblyincludes a tension knob for adjusting tension on the deflection member.4. A deflectable introducer of claim 1, wherein the shaft includes asofter distal section.
 5. A deflectable introducer of claim 1, whereinthe shaft includes a distal tip with a conical cross-section.
 6. Adeflectable introducer of claim 1, wherein the shaft includes at leastan off-axis channel through which the distal tensile member extends. 7.A deflectable introducer of claim 1, wherein the rotatable memberincludes a second pulley around which another tensile member proximalportion is wrapped, wherein manipulation of the deflection member in anopposition direction draws on the tensile member for deflecting thedeflectable section of the shaft in the opposite direction.
 8. Adeflectable introducer of claim 1, wherein the shaft includes a ringwith a radial passage through which a distal portion of the distaltensile member extends for anchoring the distal portion of the distaltensile member
 9. A deflectable introducer of claim 8, wherein thepassage includes two radial passages connected by a circumferentialpassage.
 10. A deflectable introducer for use with a device for passageinto a patient's body, the introducer comprising: a shaft with adeflectable section, the shaft having a lumen through which the devicecan extend; an elongated control handle defining a longitudinal axis;tensile members extending between the deflectable section and thecontrol handle, wherein the control handle has a deflection assemblycomprising a deflection member and a rotatable member, the deflectionmember being rotatable about an axis generally perpendicular to thelongitudinal axis of the control handle, the rotatable member beingrotationally coupled to the deflection member, the rotatable memberhaving a first and a second pulleys, each engaged with a proximaltensile member portion situated within the control handle; whereinrotation of the deflection member in one direction rotates the rotatablemember such that the first pulley draws on its respective proximaltensile member portion for deflecting the deflectable section of theshaft in the one direction, and rotation of the deflection in the otherdirection rotates the rotatable member such that the second pulley drawson its respective proximal tensile member portion for deflecting thedeflectable section of the shaft in another direction.
 11. A deflectableintroducer of claim 10, wherein the control handle further comprises atension knob adapted for operator manipulation in adjusting ease atwhich the deflection member can be rotated.
 12. A deflectable introducerof claim 10, wherein the shaft extends through the rotatable member. 13.A deflectable introducer of claim 10, wherein distal ends of the tensilemember are joined to each other.
 14. A deflectable introducer of claim10, wherein each tensile member comprises a connector connecting itsdistal portion and proximal portion with in the control handle.
 15. Adeflectable introducer of claim 14, wherein the distal portion comprisespuller wire and proximal portion comprises fiber.
 16. A deflectableintroducer of claim 15, wherein the puller wire extends in off-axischannels in the shaft and the fiber extends outside of the shaft.
 17. Adeflectable introducer of claim 12, wherein the rotatable member has acutout to allow rotation of the rotatable member with the shaftextending therethrough.
 18. A deflectable introducer of claim 1, whereinthe shaft includes a distal tip section that is softer than thedeflectable section.
 19. A deflectable introducer of claim 1, whereinthe shaft has off axis channels formed therein through which the tensilemembers extend.
 20. A deflectable introducer of claim 19, wherein theshaft has a lining and an outer layer and the off-axis channels areformed in the outer layer.